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临床试验/NCT05186649
NCT05186649Unknown不适用

Left Atrial Appendage (LAA) Clot With Severe Mitral Stenosis, Responders and Non-responders With Anticoagulation

University of Karachi1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2021年12月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
52
试验地点
1
主要终点
frequency of left atrial appendage

研究概览

简要总结

Consecutive patients with severe mitral stenosis and clot in left atrial appendage (LAA) on transesophageal echocardiography fulfilling the inclusion criteria will be recruited for this study. An ACUSON 128-XP echocardiographic system equipped with omniplane and biplane transesophageal probes will be used for this study. TEE followed by CT Angiography will be performed according to the standard procedure after obtaining informed consent.

详细描述

Consecutive patients with severe mitral stenosis and clot in left atrial appendage (LAA) on transesophageal echocardiography fulfilling the inclusion criteria will be recruited for this study. An ACUSON 128-XP echocardiographic system equipped with omniplane and biplane transesophageal probes will be used for this study. TEE followed by CT Angiography will be performed according to the standard procedure after obtaining informed consent. Demographic profile of the patients will be recorded like gender and age. And baseline TEE will be interpreted and parameters such as mean MVO (cm2), mean MPG (mmHg), and mean LA size (AP diameter, cm) will be recorded. LAA morphologies will be classified as per the operational definition. All the patients will be put on oral anticoagulation with Warfarin. The international normalized ratio (INR) will be maintained between 2.5 and 3.5. Patients will be prescribed with warfarin initial with 5 mg of daily dosage. Weekly INR monitoring will be performed via weekly calls to each and every patients and their INR level will be obtained. Warfarin daily dosage will be adjusted after every month based on target INR range. Repeat TEE will be performed after three (3) months in all the patients. And presence and absence of clot in different types of LAA will be recorded.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18 to 65 years.
  • Both male and female.
  • Patients with server mitral stenosis.
  • Patients with LAA clot on TEE.
  • Patients prescribed with anticoagulation (warfarin therapy).

排除标准

  • Patients with severe MR
  • Patients with severe AS
  • Patients with NYHA class IV
  • Patients whose valve morphology precluded PTMC

结局指标

主要结局

frequency of left atrial appendage

时间窗: 6 Month

To determine frequency of left atrial appendage (LAA) clot resolution after three months of anticoagulation in patients with severe mitral stenosis.

次要结局

  • anatomies of LAA(6 Month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Tariq Ashraf

Professor

University of Karachi

研究点 (1)

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